Esophageal Cooling During Ablation for Atrial Fibrillation

(eCool-US Trial)

Recruiting at 10 trial locations

Overseen By David Callans, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Advanced Cooling Therapy, Inc., d/b/a Attune Medical

Disqualifiers: Inability to consent, Age <18 or >85, Recent ablation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Day 0

152 Participants Needed

Trial Summary

What is the purpose of this trial?

Atrial fibrillation (AF) is a common debilitating heart rhythm condition that can cause heart failure and negatively impact a patient's outlook in terms of symptoms and disability. It is an irregular fast heart rhythm disorder coming from the top chamber of the heart (left atrium). Catheter ablation treatment has been shown to be effective in controlling or eliminating AF and its associated symptoms. This is now a common and effective treatment option for patients suffering with AF. During ablation, thermal energy is applied in the top chamber of the heart (the left atrium) to abolish abnormal electrical signals that cause AF. It is generally a safe procedure, but one potential risk associated with this procedure is damage to the esophagus caused by thermal energy being transmitted to the esophagus from the heart. The esophagus sits just behind the heart chamber where ablation work is performed, about 5mm away, so it is vulnerable to damage. Although the risk of severe esophageal damage is low, if it occurs it can be serious as the patient may become very ill as a result. In recent studies, it was shown that a more advanced type of esophageal probe (ensoETM) that cools the esophagus during ablation is better at protecting the esophagus from ablation-related injury compared to the standard care temperature monitoring probe currently used. The ensoETM is a CE marked and FDA-cleared device, with an intended purpose of controlling patient temperature and has received marketing authorization from FDA to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures. The purpose of this study is to determine if the long-term efficacy outcome results obtained in single pilot studies can be replicated in a prospective, multi-center randomized controlled trail comparing the the esophageal cooling probe versus a standard of care esophageal temperature monitoring probe. There is a 50:50 chance of the esophageal cooling probe being used during AF ablation for participants.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. It's best to consult with the trial coordinators or your doctor for guidance.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the idea that Esophageal Cooling During Ablation for Atrial Fibrillation is an effective treatment?

The available research shows that using the ensoETM, an esophageal cooling device, can reduce thermal injury to the esophagus during radiofrequency ablation for atrial fibrillation. This is important because such injuries can lead to serious complications. However, some studies indicate that esophageal temperature monitoring alone does not significantly reduce the risk of esophageal injury compared to not using it. More research is needed to fully understand the effectiveness of esophageal cooling during this treatment. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment ensoETM for esophageal cooling during atrial fibrillation ablation?

The ensoETM device has been shown to reduce thermal injury to the esophagus during radiofrequency ablation for atrial fibrillation, which is important because such injuries can lead to serious complications. ^{1 2 3 4 5}

What safety data exists for esophageal cooling during AF ablation?

The safety data for esophageal cooling during atrial fibrillation (AF) ablation is mixed. Studies have evaluated different temperature monitoring probes and their impact on esophageal injury. A meta-analysis found no significant difference in esophageal injury rates between groups with and without luminal esophageal temperature (LET) monitoring, indicating that the role of temperature monitoring in reducing esophageal thermal lesions is not yet established. Some studies suggest that multi-sensor probes may increase the detection of intraluminal temperature and risk of esophageal injury compared to single-sensor probes. Overall, more randomized controlled trials are needed to assess the true impact of esophageal cooling and temperature monitoring on safety during AF ablation. ^{1 2 4 5 6}

Is esophageal cooling during atrial fibrillation ablation safe for humans?

Esophageal cooling during atrial fibrillation ablation has been studied to see if it can reduce the risk of esophageal injury, which is a potential complication of the procedure. Some studies suggest that monitoring esophageal temperature might help, but the results are not conclusive, and more research is needed to confirm its safety and effectiveness. ^{1 2 4 5 6}

Is esophageal cooling a promising treatment during atrial fibrillation ablation?

Yes, esophageal cooling, like the ensoETM device, is promising because it helps reduce the risk of thermal injury to the esophagus during atrial fibrillation ablation, which can prevent serious complications. ^{1 2 3 5 6}

How is esophageal cooling during ablation for atrial fibrillation different from other treatments?

Esophageal cooling with the ensoETM device is unique because it actively cools the esophagus during atrial fibrillation ablation, reducing the risk of thermal injury, which can lead to serious complications like atrioesophageal fistula. This approach is different from standard temperature monitoring, which only observes temperature changes without actively preventing them. ^{1 2 3 5 6}

Research Team

David Callans, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for AF patients suitable for ablation treatment under general anesthesia, as per guidelines. They must have already decided on this procedure and be waiting for it. It's not open to those who can't consent, can't follow up with endoscopy, are younger than 18 or older than 85, or have a history of upper GI tract bleeding or esophageal conditions that contraindicate instrumentation during ablation.

Inclusion Criteria

I am approved for and waiting for AF ablation treatment under general anesthesia.

Exclusion Criteria

I am between 18 and 85 years old.

I am unable to give consent for medical procedures.

You cannot have the follow-up endoscopy for any reason.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo AF ablation with either the esophageal cooling probe or standard temperature monitoring probe under general anesthesia

Day 0

1 visit (in-person)

Follow-up

Participants may have an optional endoscopy camera between 12-72 hours post-ablation to assess esophageal thermal damage

12-72 hours post-ablation

1 visit (in-person)

Long-term Follow-up

Participants are monitored for freedom from atrial arrhythmia and incidence of major adverse events at 3, 6, and 12 months post-ablation

12 months

3 visits (in-person or virtual)

Treatment Details

Interventions

• ensoETM. Esophageal cooling during AF ablation
• Esophageal temperature monitoring probe

Trial Overview The study compares the safety of two probes during AF ablation: a new cooling probe designed to protect the oesophagus from heat damage versus the standard temperature monitoring probe. Participants will be randomly assigned in equal chance to receive either the new cooling probe or standard care.

Participant Groups

Group I: Study group Active Control 1 Intervention

Those randomized to the study group will receive the esophageal cooling device- the ensoETM probe, during AF ablation treatment, under general anaesthetic. The cooling device is set to 4 degrees Celsius during ablation of the left atrial posterior wall.

Group II: Control group Active Control 1 Intervention

Those randomized to the control group will receive standard of care, which is an esophageal temperature monitoring probe during their AF ablation procedure, under general anesthetic. The esophageal temperature probe is placed close to the level of ablation (the probe should be at the esophageal level where, opposite this, the ablation catheter is at, in the endocardial aspect of the posterior left atrium).

ensoETM. Esophageal cooling during AF ablation is already approved in European Union, United States for the following indications:

Approved in European Union as ensoETM for:

• Esophageal protection during atrial fibrillation ablation

Approved in United States as ensoETM for:

• Reducing the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures

Who Is Running the Clinical Trial?

Advanced Cooling Therapy, Inc., d/b/a Attune Medical

Lead Sponsor

Trials

7

Recruited

270+

Kansas City Cardiac Arrhythmia Research LLC

Collaborator

Trials

1

Recruited

150+

Attune Medical

Collaborator

Trials

6

Recruited

690+

The Queen Elizabeth Hospital

Collaborator

Trials

45

Recruited

27,000+

Berry Consultants

Collaborator

Trials

16

Recruited

58,200+

Guy's and St Thomas' NHS Foundation Trust

Collaborator

Trials

399

Recruited

1,004,000+

Royal Brompton & Harefield NHS Foundation Trust

Collaborator

Trials

236

Recruited

150,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Texas Cardiac Arrhythmia Research Foundation

Collaborator

Trials

40

Recruited

15,400+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Findings from Research

In a study of 100 patients undergoing atrial fibrillation ablation, the incidence of esophageal injuries was similar between two types of temperature probes used for monitoring, with 20% injuries in the multi-thermocouple group and 30% in the deflectable probe group.

Most esophageal lesions were mild to moderate and resolved with conservative treatment, indicating that while esophageal injuries can occur during the procedure, they are generally not severe and can be managed effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidences of esophageal injury during esophageal temperature monitoring: a comparative study of a multi-thermocouple temperature probe and a deflectable temperature probe in atrial fibrillation ablation. Kuwahara, T., Takahashi, A., Takahashi, Y., et al.[2021]

In a meta-analysis of 4 non-randomized controlled trials involving 411 patients, esophageal temperature monitoring during radiofrequency ablation for atrial fibrillation did not significantly reduce the incidence of thermal esophageal injuries compared to no monitoring, with injury rates of 8.9% and 6.8%, respectively.

The study highlights the need for more rigorous research, including randomized controlled trials, to better understand the effectiveness of esophageal temperature monitoring in preventing thermal injuries during atrial fibrillation ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esophageal Temperature Monitoring During Radiofrequency Ablation of Atrial Fibrillation: A Meta-Analysis. Koranne, K., Basu-Ray, I., Parikh, V., et al.[2020]

Active esophageal cooling during radiofrequency ablation for atrial fibrillation significantly reduces the risk of thermal injury to the esophagus, which can lead to life-threatening complications like atrioesophageal fistula.

This cooling technique not only enhances patient safety by minimizing esophageal damage but also improves procedural efficiency, leading to shorter procedure times, less postoperative pain, and higher rates of same-day patient discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active esophageal cooling during radiofrequency ablation of the left atrium: data review and update. Cooper, J., Joseph, C., Zagrodzky, J., et al.[2023]

In a study of 543 patients undergoing RF ablation for atrial fibrillation, the multi-sensor temperature probe detected higher intraluminal esophageal temperatures (≥ 39°C) in 75% of cases compared to 39% with the single-sensor probe, indicating better monitoring capability.

Despite the multi-sensor probe detecting more cases of elevated esophageal temperature, the severity of esophageal injuries was similar between the two groups, suggesting that while the multi-sensor probe is more sensitive, it may not provide a significant advantage in preventing severe injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-sensor esophageal temperature probe used during radiofrequency ablation for atrial fibrillation is associated with increased intraluminal temperature detection and increased risk of esophageal injury compared to single-sensor probe. Carroll, BJ., Contreras-Valdes, FM., Heist, EK., et al.[2022]

In a study of 445 patients undergoing catheter ablation for atrial fibrillation, the use of a multi-sensor esophageal temperature probe significantly reduced the incidence of endoscopically detected esophageal lesions (EDEL) compared to a single-sensor probe, with EDEL rates of 6.8% versus 24.3% during cryoballoon ablation.

The multi-sensor probe also showed a lower incidence of EDEL in patients undergoing radiofrequency ablation (19.5% vs 32.8%), indicating that using this technology can enhance safety during AFib ablation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esophageal luminal temperature monitoring using a multi-sensor probe lowers the risk of esophageal injury in cryo and radiofrequency catheter ablation for atrial fibrillation. Abdulsalam, NM., Sridhar, AM., Tregoning, DM., et al.[2023]

In a study of 76 patients undergoing catheter ablation for atrial fibrillation, 50% received esophageal cooling during the procedure, but this method did not significantly reduce the incidence of esophageal thermal lesions (ETL).

While there was a non-significant trend indicating fewer severe lesions in the cooled group (13.5% vs. 29% in the non-cooled group), the overall results suggest that esophageal cooling may not be an effective strategy to prevent ETL during ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of esophageal cooling on esophageal injury during radiofrequency catheter ablation of atrial fibrillation. John, J., Garg, L., Orosey, M., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Incidences of esophageal injury during esophageal temperature monitoring: a comparative study of a multi-thermocouple temperature probe and a deflectable temperature probe in atrial fibrillation ablation. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Esophageal Temperature Monitoring During Radiofrequency Ablation of Atrial Fibrillation: A Meta-Analysis. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Active esophageal cooling during radiofrequency ablation of the left atrium: data review and update. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Multi-sensor esophageal temperature probe used during radiofrequency ablation for atrial fibrillation is associated with increased intraluminal temperature detection and increased risk of esophageal injury compared to single-sensor probe. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Esophageal luminal temperature monitoring using a multi-sensor probe lowers the risk of esophageal injury in cryo and radiofrequency catheter ablation for atrial fibrillation. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of esophageal cooling on esophageal injury during radiofrequency catheter ablation of atrial fibrillation. [2021]